Surgical Removal of Prostate Tumor and Antiandrogen Therapy with or without Docetaxel in Treating Men with Newly Diagnosed Metastatic Prostate Cancer
- Histologically proven adenocarcinoma of the prostate
- Evidence of metastasis by magnetic resonance imaging (MRI)/computed tomography (CT) scan, bone scan, or histologic confirmation
- Clinical stage M1a (distant lymph node positive), or M1b (bone metastasis)
- If solitary lesion, metastasis confirmed with either biopsy or two independent imaging modalities (i.e. CT and PET [positron emission tomography], bone scan and MRI, modality at the discretion of the treating physician)
- No previous local therapy for prostate cancer
- Give informed consent
- Prostate deemed resectable by surgeon
- Started antiandrogen therapy (ADT) no longer than 6 months prior to randomization
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Hemoglobin (HgB) >= 9 g/dL compatible for surgery
- Platelets > 80,000 compatible for surgery
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2 x upper limit of normal (ULN) compatible for surgery
- Refuses to give informed consent
- Deemed to have unresectable disease by surgeon
- Received ADT for more than 6 months prior to randomization
- Life expectancy of less than 6 months prior to randomization
- Known spinal cord compression
- M1c disease (solid organ metastasis)
- Deep vein thrombosis (DVT)/pulmonary embolism (PE) in the past 6 months prior to randomization
- Previous local therapy for prostate cancer
- Previous chemotherapy for prostate cancer
- Patients who have chemotherapy, radiotherapy or oral antifungal agents (ketoconazole, itraconazole, fluconazole) within 3 weeks prior to entering the study or those who have not recovered (e.g. back to baseline or grade 1) from adverse events due to agents administered more than 3 weeks earlier
- Any drug interactions that are deemed to be medically significant would require a washout of 5-half-lives of the interaction agent before enrollment can occur
I. To assess the clinical benefit of combining radical surgery – cytoreductive radical prostatectomy (CRP) - with the best systemic therapy (BST) in men with newly diagnosed clinical M1a or M1b metastatic prostate cancer (mPCa).
I. To determine the impact of CRP+BST on time to biochemical progression, cancer-specific survival, complication rates, and quality of life (QOL) in patients with mPCa.
II. To determine the transcription levels of bone morphogenetic protein -6 (BMP-6) and transforming growth factor-beta (TGF-beta).
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants receive antiandrogen therapy with or without docetaxel at the discretion of the treating physician.
ARM II: Participants receive antiandrogen therapy for at least 1 month, then undergo cytoreductive radical prostatectomy. Participants continue antiandrogen therapy and may receive docetaxel within 3 months after surgery at the discretion of the treating physician.
After completion of study treatment, patients are followed up every 6 months from time of progression.
Trial Phase Phase II
Trial Type Treatment
Rutgers Cancer Institute of New Jersey
Isaac Yi Kim
- Primary ID 081707
- Secondary IDs NCI-2018-00047
- Clinicaltrials.gov ID NCT03456843